ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

Last updated: April 7, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Focal Segmental Glomerulosclerosis

Renal Failure

Nephropathy

Treatment

Ravulizumab

Placebo

Clinical Study ID

NCT05746559
D928DC00001
2022-501802-36
ALXN1210-CSA-AKI-318
  • Ages 18-90
  • All Genders

Study Summary

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant weighs ≥ 30 kg

  • Planned non-emergent sternotomy with CPB procedure for the following surgeries:

  • Multi-vessel CABG

  • Valve replacement or repair; ascending aorta surgery permitted if combined withaortic valve replacement/repair

  • Combined CABG and valve surgery; inclusion of single-vessel CABG when combined withvalve replacement/repair is permitted

  • Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)

Exclusion

Exclusion Criteria:

  • Emergency or salvage cardiac surgery is expected at screening or randomization, asassessed by the investigator.

  • Single-vessel CABG without valve surgery is planned.

  • Off-pump surgery is planned (eg, surgery without CPB).

  • Recipient of a solid organ or bone marrow transplantation.

  • Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump,extracorporeal membrane oxygenation, or left ventricular assist device within 72hours of randomization.

  • Active systemic bacterial, viral, or fungal infection within 14 days prior torandomization.

  • History of unexplained, recurrent infection.

  • Any use of KRT or presence of AKI within 30 days of randomization

  • Use of any complement inhibitors, or plasmapheresis or plasma exchange within theyear prior to Screening, or planned use during the course of the study.

  • Participant is not willing to be vaccinated against N meningitidis or is unwillingto receive prophylactic treatment with appropriate antibiotics , if needed

  • History of or unresolved N meningitidis infection.

Study Design

Total Participants: 736
Treatment Group(s): 2
Primary Treatment: Ravulizumab
Phase: 3
Study Start date:
April 06, 2023
Estimated Completion Date:
February 17, 2027

Connect with a study center

  • Research Site

    Buenos Aires, C1180AAV
    Argentina

    Active - Recruiting

  • Research Site

    Caba, C1428DCO
    Argentina

    Active - Recruiting

  • Research Site

    Ciudad Autónoma de Bs. As., C1199ABB
    Argentina

    Active - Recruiting

  • Research Site

    Cordoba, X5000 FAL
    Argentina

    Site Not Available

  • Research Site

    Corrientes, W3400AMZ
    Argentina

    Active - Recruiting

  • Research Site

    Córdoba, X5016LIG
    Argentina

    Site Not Available

  • Research Site

    San Luis, 5700
    Argentina

    Active - Recruiting

  • Research Site

    Santa Fé, S3000EOM
    Argentina

    Active - Recruiting

  • Research Site

    Adelaide, 5000
    Australia

    Site Not Available

  • Research Site

    Brisbane, 4102
    Australia

    Active - Recruiting

  • Research Site

    Canberra, 2605
    Australia

    Site Not Available

  • Research Site

    Heidelberg, 3081
    Australia

    Site Not Available

  • Research Site

    Monash,
    Australia

    Active - Recruiting

  • Research Site

    Murdoch, 6150
    Australia

    Active - Recruiting

  • Research Site

    Southport, 4215
    Australia

    Active - Recruiting

  • Research Site

    Belo Horizonte, 30150-221
    Brazil

    Active - Recruiting

  • Research Site

    Brasillia, 70658-700
    Brazil

    Site Not Available

  • Research Site

    Campinas, 13060-080
    Brazil

    Site Not Available

  • Research Site

    Fortaleza, 60430-375
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre, 90620-001
    Brazil

    Site Not Available

  • Research Site

    Recife, 50070-550
    Brazil

    Active - Recruiting

  • Research Site

    Ribeirão Preto, 14051-140
    Brazil

    Active - Recruiting

  • Research Site

    Rio de Janeiro, 22270-005
    Brazil

    Suspended

  • Research Site

    S.J. Do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • Research Site

    Salvador, 40301-155
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 04012-180
    Brazil

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Research Site

    Winnipeg, Manitoba R2H 2A6
    Canada

    Site Not Available

  • Research Site

    Saint John, New Brunswick E2L 4L4
    Canada

    Active - Recruiting

  • Research Site

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • Research Site

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H2X 0C1
    Canada

    Active - Recruiting

  • Research Site

    Montréal, Quebec H1T 1C8
    Canada

    Active - Recruiting

  • Research Site

    Beijing, 100029
    China

    Site Not Available

  • Research Site

    Fuzhou, 350001
    China

    Site Not Available

  • Research Site

    Gaozhou, 525232
    China

    Site Not Available

  • Research Site

    Guangzhou, 510120
    China

    Site Not Available

  • Research Site

    Hangzhou, 310014
    China

    Site Not Available

  • Research Site

    Huai'an, 223300
    China

    Site Not Available

  • Research Site

    Ningbo, 315100
    China

    Active - Recruiting

  • Research Site

    Shanghai, 200032
    China

    Active - Recruiting

  • Research Site

    Shenzhen, 518036
    China

    Active - Recruiting

  • Research Site

    Tianjin, 300050
    China

    Active - Recruiting

  • Research Site

    Wuhan, CN-430022
    China

    Site Not Available

  • Research Site

    Xi'an, 710061
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450052
    China

    Active - Recruiting

  • Research Site

    Zhengzhou City, 450000
    China

    Site Not Available

  • Research Site

    Zunyi, 563100
    China

    Site Not Available

  • Research Site

    Bordeaux Cedex, 33074
    France

    Active - Recruiting

  • Research Site

    Dijon Cedex, 21079
    France

    Active - Recruiting

  • Research Site

    Montpellier, 34000
    France

    Active - Recruiting

  • Research Site

    Toulouse Cedex 3, 31076
    France

    Active - Recruiting

  • Research Site

    Dresden, 01307
    Germany

    Site Not Available

  • Research Site

    Essen, 45147
    Germany

    Active - Recruiting

  • Research Site

    Frankfurt am Main, 60590
    Germany

    Active - Recruiting

  • Research Site

    Giessen, 35392
    Germany

    Active - Recruiting

  • Research Site

    Halle (Saale), 06120
    Germany

    Active - Recruiting

  • Research Site

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Research Site

    Jena, 07747
    Germany

    Suspended

  • Research Site

    Muenster, 48149
    Germany

    Site Not Available

  • Research Site

    München, 81377
    Germany

    Active - Recruiting

  • Research Site

    Stuttgart, 70376
    Germany

    Active - Recruiting

  • Research Site

    Trier, 54292
    Germany

    Active - Recruiting

  • Research Site

    Hong Kong, 999077
    Hong Kong

    Active - Recruiting

  • Research Site

    Bangalore, 560092
    India

    Active - Recruiting

  • Research Site

    Delhi, 110060
    India

    Active - Recruiting

  • Research Site

    Gurgaon, 122001
    India

    Active - Recruiting

  • Research Site

    Hyderabad, 500 034
    India

    Active - Recruiting

  • Research Site

    Mysuru, 570004
    India

    Active - Recruiting

  • Research Site

    Secunderabad, 500003
    India

    Active - Recruiting

  • Research Site

    Haifa, 34362
    Israel

    Suspended

  • Research Site

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Research Site

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Research Site

    Bari, 70124
    Italy

    Active - Recruiting

  • Research Site

    Firenze, 50134
    Italy

    Active - Recruiting

  • Research Site

    Milan, 20138
    Italy

    Active - Recruiting

  • Research Site

    Milano, 20121
    Italy

    Site Not Available

  • Research Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • Research Site

    Bunkyo-ku, 113-8431
    Japan

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-8560
    Japan

    Active - Recruiting

  • Research Site

    Kamakura-shi, 247-8533
    Japan

    Active - Recruiting

  • Research Site

    Kawasaki-shi, 216-8511
    Japan

    Active - Recruiting

  • Research Site

    Minato-ku, 105-8470
    Japan

    Active - Recruiting

  • Research Site

    Okayama-shi, 700-0804
    Japan

    Active - Recruiting

  • Research Site

    Sagamihara-shi, 252-0375
    Japan

    Active - Recruiting

  • Research Site

    Suginami, 168-0065
    Japan

    Active - Recruiting

  • Research Site

    Urayasu, 279-0001
    Japan

    Active - Recruiting

  • Research Site

    Anyang-si, 14068
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Bucheon-si, 14754
    Korea, Republic of

    Site Not Available

  • Research Site

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Daegu, 42601
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seongnam-si, 13620
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Research Site

    Maastricht, 6229 HX
    Netherlands

    Active - Recruiting

  • Research Site

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Research Site

    Białystok, 15-276
    Poland

    Site Not Available

  • Research Site

    Bielsko-Biała, 43-316
    Poland

    Active - Recruiting

  • Research Site

    Chrzanów, 32-500
    Poland

    Active - Recruiting

  • Research Site

    Grudziądz, 86-300
    Poland

    Site Not Available

  • Research Site

    Katowice, 40-635
    Poland

    Site Not Available

  • Research Site

    Kraków, 31-202
    Poland

    Site Not Available

  • Research Site

    Lodz, 91-347
    Poland

    Site Not Available

  • Research Site

    Poznań, 60-355
    Poland

    Completed

  • Research Site

    Szczecin, 70-111
    Poland

    Active - Recruiting

  • Research Site

    Tychy, 43-100
    Poland

    Active - Recruiting

  • Research Site

    Warszawa, 02-972
    Poland

    Active - Recruiting

  • Research Site

    Łódź, 91-347
    Poland

    Completed

  • Research Site

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Research Site

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Research Site

    A Coruna, 15006
    Spain

    Active - Recruiting

  • Research Site

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Research Site

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Research Site

    Majadahonda, 28250
    Spain

    Active - Recruiting

  • Research Site

    Navarra, 31190
    Spain

    Active - Recruiting

  • Research Site

    Santander, 39008
    Spain

    Site Not Available

  • Research Site

    Sevilla, 41071
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46010
    Spain

    Active - Recruiting

  • Research Site

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Research Site

    Hualien City, 970473
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung, 83301
    Taiwan

    Active - Recruiting

  • Research Site

    New Taipei, 220
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 11696
    Taiwan

    Active - Recruiting

  • Research Site

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Research Site

    Antalya, 07100
    Turkey

    Site Not Available

  • Research Site

    Istanbul, 34846
    Turkey

    Active - Recruiting

  • Research Site

    Menemen/Izmir, 35665
    Turkey

    Site Not Available

  • Research Site

    Odunpazarı, 26080
    Turkey

    Site Not Available

  • Research Site

    Cambridge, CB2 0AY
    United Kingdom

    Active - Recruiting

  • Research Site

    Clydebank, G81 4DY
    United Kingdom

    Active - Recruiting

  • Research Site

    Edinburgh, EH16 4SA
    United Kingdom

    Active - Recruiting

  • Research Site

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • Research Site

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Active - Recruiting

  • Research Site

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Active - Recruiting

  • Research Site

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Research Site

    Stanford, California 94305
    United States

    Active - Recruiting

  • Research Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Research Site

    Washington, District of Columbia 20037-2342
    United States

    Site Not Available

  • Research Site

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32804
    United States

    Site Not Available

  • Research Site

    Weston, Florida 33331
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Research Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Research Site

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • Research Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Research Site

    Springfield, Massachusetts 01107
    United States

    Active - Recruiting

  • Research Site

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Research Site

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Research Site

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Research Site

    Haddon Heights, New Jersey 08035
    United States

    Site Not Available

  • Research Site

    Rochester, New York 14621
    United States

    Active - Recruiting

  • Research Site

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Research Site

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Research Site

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Research Site

    Fargo, North Dakota 58102
    United States

    Active - Recruiting

  • Research Site

    Cleveland, Ohio 44126
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Research Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Plano, Texas 75093
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Research Site

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Research Site

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Research Site

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Research Site

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research Site

    Wisconsin Rapids, Wisconsin 54494
    United States

    Active - Recruiting

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